Nutritional Optimization and Bone Health Management for Older Adults Undergoing Hip Fracture Surgery

Nutritional Optimization and Bone Health Management for Older Adults Undergoing Hip Fracture Surgery: A Pilot Study

The overall objective of this pilot study is to test a comprehensive nutritional intervention in elderly patients diagnosed with hip fracture, which the study team believe will reduce functional decline, morbidity and mortality.

Study Overview

• Status: Completed
• Conditions: Hip Fractures
• Intervention / Treatment: Drug: Juven; Drug: Centrum Silver 50+

Detailed Description

This collaborative pilot study is led by a PI who is a board-certified orthopaedic surgeon with extensive experience in the care of older adults with hip fractures. In addition, the multidisciplinary study team includes a research health scientist with vast experience in nutrition, preventive health, and gerontology. The study team will also be supported by a physical therapist and researcher in the field of rehabilitation of older adults with musculoskeletal disorders. Furthermore, an occupational therapist with expertise in rehabilitation science, conduct of pilot studies, and analysis of interview data will play an important role in this study. Moreover, the statistical analyses will be performed by an expert statistical consultant from our institution, who will be reimbursed on a fee for service basis.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • University Health System
    • San Antonio, Texas, United States, 78229
      • UT Health San Antonio Department of Orthopedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Male or female, aged 65-89 years
3. Closed fracture of the proximal femur including the anatomic areas of femoral neck, intertrochanteric and subtrochanteric region
4. Patient indicated for surgical treatment (surgical fixation or arthroplasty) as per orthopaedic surgeon
5. Ability to take oral medication and be willing to adhere to the study drug regimen and to the nutritional guidance provided by nutritional experts.

Exclusion Criteria:

1. Patients with open fractures
2. Surgical treatment other than surgical fixation or arthroplasty, such as proximal femur resection
3. Known allergic reactions to components of the study drugs or who do not tolerate oral nutritional supplementation (e.g. total parenteral nutrition or food allergies)
4. Decisional impairment
5. Prisoners

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutritional Supplements; Juven and Centrum Silver 50+ will be administered to this group	Drug: Juven; Nutritional supplements; Other Names: Conditionally essential amino acids; Drug: Centrum Silver 50+; Over the counter nutritional supplement; Other Names: Multivitamin/multimineral
No Intervention: Control; Standard of care procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of surgical complications at 26 weeks	Number of subjects that experienced any complications post surgery	26 weeks (post surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Readmissions	Number of hospital re-admissions	26 weeks (post surgery)
Secondary fractures	Number of secondary fractures that occurred post surgery	26 weeks (post surgery)
Grip strength	Change in grip strength from pre- to post-surgery using a hand dynamometer and measured in pounds	Baseline to 26 weeks
Quality of Life Survey (Short-form 36 Health (SF-36))	Change in Health related quality of life (QOL) survey, a 36 item survey. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.	Baseline to 26 weeks

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Boris Zelle, MD, University of Texas Health Science Center San Antonio

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2023
• Primary Completion (Actual): December 10, 2024
• Study Completion (Actual): June 4, 2025

Study Registration Dates

• First Submitted: July 14, 2023
• First Submitted That Met QC Criteria: July 31, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Estimated): October 14, 2025
• Last Update Submitted That Met QC Criteria: October 13, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Older adults; Hip surgery
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Femoral Fractures; Hip Injuries; Hip Fractures; Geritol
• Other Study ID Numbers: HSC20230182H; 5P30AG044271 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected deidentified IPD, that underlie results in a publication
• IPD Sharing Time Frame: At the time of publication in a peer reviewed journal
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No